BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool)

    Reg #: 1220452 · FEI: 1220452 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC VASCULAR
    Registration Number
    1220452
    FEI Number
    1220452
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    37A Cherry Hill Dr
    City
    DANVERS
    State
    MA
    ZIP
    01923
    Country
    US

    Regulatory Submissions

    510(k) Number
    K923638

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool) PTCA Accessory Pack (Y-Adaptor w/Hemostasis Valve, Stretch Insertion Tool, Steering Handle, Sterile Sleeve)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility